510(k) K003342 ยท DCN System, Test, C-Reactive Protein
WAKO CRP-UL, CRP-UL CALIBRATOR SET
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Oct 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003342
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.